Study of the Influence of Blue Light Emitted by Computer / Television Screens on Melasma MELABLUE… (NCT03877445) | Clinical Trial Compass
CompletedNot Applicable
Study of the Influence of Blue Light Emitted by Computer / Television Screens on Melasma MELABLUE Study
France12 participantsStarted 2019-04-11
Plain-language summary
Melasma is a fairly common condition resulting in hyperpigmented macules on the face. Melasma is difficult to treat and has a significant negative impact on the patient's quality of life.
Melasma is worsen when exposed to high energy visible light (blue and violet light) of the solar spectrum. Blue light emitted by LED screens from computers, tablets, televisions and even mobile phones is currently suspected (via media channels) to induce harmful effects on the skin, including pigmentation and photoaging. These screens, however, emit much lower irradiances than those of the solar spectrum, and the probability that these irradiances impact the skin is very low.
The objective of the study is to assess the effect of blue light emitted by computer/television screens on the intensity of melasma pigmentation. To do this, it is proposed to use maximized conditions that could be encountered in normal daily life, namely a simulation of blue light exposure (420-490nm) at 20 cm from a laptop LED screen, 8 hours a day for 5 days. Since it is not proposed to expose a person for 8 hours a day, a solar simulator with appropriate filters will be used to emit a spectrum of between 420 and 490 nm with a compatible intensity for an acceptable duration of exposure (around 30 minutes a day).
Twelve patients will be included in the study and exposed on a half-face from Day1 to Day5. The other half-face will serve as unexposed control. The effect of blue light on the melasma lesions will be assessed from Day 1 to Day 6 using chromametry and a modified MASI on standardized photographs. A final evaluation visit will be performed at Day 15.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patient, 18 years of age and older, phototype II to V on the Fitzpatrick scale
* Patient with a clinically diagnosed diagnosis of melasma.
* Patient without a serious medical history and declared fit to participate in the medical visit.
* Patient who has signed a written informed consent form before any action related to the study is initiated.
* If the patient is able to procreate, she should use reliable contraception (contraceptive pill, contraceptive implant, intrauterine contraceptive device, bilateral tubal ligation / section, condoms), and agree not to change contraceptive status for at least one month before the start of the study and throughout the duration of the study.
Exclusion Criteria:
* Women who are pregnant or breastfeeding or who have planned a pregnancy during the course of the study.
* Patient with another pigment condition on the face.
* Patient who used depigmenting cosmetic on the face in the two weeks prior to inclusion.
* Patient who used a local corticosteroid on the face or systemic steroids during the month prior to inclusion.
* Patient who used local tretinoin or local hydroquinone during the month prior to inclusion.
* Patient who took systemic or topical photosensitizing treatments during the month preceding the first day of the study (1 month or 5 half-lives, the longest possible duration),
* Patient with a history of photodermatoses.
* Patient spending more than 3 hours a day in front of a screen (computer, LED …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the effect of blue light emitted by computer / television screens on the intensity of pigmentation of melasma by Melasma Area and Severity Index scale